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Completed

NCT Number: NCT03574480

Smartphone Applications to Improve Lifestyles in Olders Over 65 Years

This is a randomized controlled clinical trial performed in urban primary care centers in Salamanca (Spain). Its objective is to evaluate the effect of an intervention based on the use of new information and communication technologies in a population of people over 65 years of age in the improvement of lifestyles, body composition, quality of life, cognitive performance and daily life activities.

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Key information

Conditions

Telemedicine

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Biosanitario de Salamanca. Research Unit La Alamedilla

Salamanca, 37003, Spain

About this study

  • Objective: To evaluate the effect of an intervention based on the use of new information and communication technologies in a population of people over 65 years of age.
  • Design and setting: A randomized clinical trial of two parallel groups. Population: 140 participants over 65 years of age will be included, selected by consecutive sampling in primary care centers of Salamanca (Spain.
  • Measurements and intervention: Lifestyles (physical activity, sedentarism and mediterranean diet), body composition, health-related quality of life, cognitive performance and daily life activities will be evaluated at 3 months. The advice on healthy diet and physical activity recommendations will be common to both groups. The intervention group will be added a training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent signed
  • Age between 65 and 80 years

Exclusion criteria

  • Cardiovascular disease
  • Moderate or severe chronic obstructive pulmonary disease.
  • Musculoskeletal disease that limits ambulation.
  • Severe mental illness
  • Score in the Mini-mental <24 points.
  • Oncological disease in treatment.

Treatment and study plan

Intervention (training in use of a Smartphone application)

Behavioral

The intervention group will be added a training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.

Control (Advice on healthy diet and physical activity recommendations)

Behavioral

Advice on healthy diet and physical activity recommendations

Primary outcomes

  1. Physical activity

    Time frame: 3 months

    Measurement by accelerometer (steps/day)

Secondary outcomes

  1. Body composition

    Time frame: 3 months

    Measurement by Body fat percentage (%)

  2. Cognitive performance

    Time frame: 3 months

    Measurement by MINI MENTAL STATE EXAMINATION (Score between 0 (Cognitive impairment) and 30 (normal))

  3. Improve Quality of life

    Time frame: 3 months

    Measurement by the WHOQOL-AGE scale (Score between 13 (poor quality) and 65 (high quality))

  4. Daily life activities

    Time frame: 3 months

    Measurement by PFEFFER FUNCTIONAL ACTIVITY Questionnaire (Score between 0 (normal) and 33 (Functional alteration))

  5. Sedentarism

    Time frame: 3 months

    Measurement by Marshall questionnaire (sitting time - hours/day)

  6. Adherence to the Mediterranean Diet

    Time frame: 3 months

    Measurement by the MEDAS scale (Score between 0 (poor adherence) and 14 (high adherence))

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Other

Collaborators

  • Instituto de Investigación Biomédica de Salamanca

Registry information

Official study title

Effectiveness of the Combined Use of Smartphone and Smartband Technology in the Improvement of Lifestyles in the Adult Population Over 65 Years of Age. Randomized Clinical Trial. EVIDENT Age Study

Acronym: EVIDENT-Age

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2018
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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